In March 2021, the European Commission opened a formal investigation into alleged anti-competitive – ‘pay-for-delay’ – conduct, by the Israeli generics giant Teva Pharmaceutical Industries (Teva).
Teva under scrutiny in EU pay-for-delay investigation
Home/Policies & Legislation | Posted 31/05/2021 0 Post your comment
It is suspected that Teva took action to delay the market entry of generic drugs that competed with their multiple sclerosis drug, Copaxone.
The active ingredient of Teva’s Copaxone is glatiramer acetate. The patent for this ingredient expired in 2015 and generic drugs entered the market. In response to this competition, Teva introduced a three-times-per-week version of the drug with a different dosage. This was combined with a communication campaign over which there are concerns as it may have created a false perception of health risks associated with generic versions of the drugs. In addition, Teva engaged in practices to file, enforce and selectively withdraw divisional patents. The commission sees the combination of these actions as being purposeful in attempting to block or delay market entry of Copaxone competitors.
As such, the commission is investigating two new ‘theories of harm’. These relate to Teva’s patent filing practices –the filing and selective withdrawal of divisional patents – and communication measures impeded the market entry of generic drugs.
This case follows a host of other pay-for-delay cases investigated by the commission in recent years. An early example was against Lundbeck in 2013, for which the European Court of Justice has recently upheld the decision to fine the company, following appeals .
With the new theories of harm, this case does have differences to those previously investigated. However, it is hoped that the Teva investigation will shed light on relevant legal framework under EU law. It is clear that the EU continues to take antitrust enforcement seriously and will undertake investigations to prevent anti-competitive conduct.
Teva not liable in US due to FDCA implied preemption
LATIN AMERICAN FORUM – Coming soon!
To further enhance the objectives of GaBI in sharing information and knowledge that ensure policies supportive of safe biosimilars use, we are pleased to announce that we will be launching a new section on GaBI Online and GaBI Journal, the ‘Latin American Forum’ (in Spanish) featuring the latest news and updates on research and developments in generic and biosimilar medicines in Latin America.
LATIN AMERICAN FORUM – Próximamente!
Para fomentar los objetivos de GaBI sobre la difusión de información y conocimiento sobre las políticas de apoyo que garantizan el uso seguro de medicamentos biosimilares, nos complace anunciar el lanzamiento de una nueva sección en GaBI Online y GaBI Journal, el ‘Latin American Forum’ (en español), que presentará las últimas noticias y actualizaciones en investigación y desarrollo sobre medicamentos genéricos y biosimilares en Latinoamérica.
1. GaBI Online - Generics and Biosimilars Initiative. EU Court of Justice upholds Lundbeck fines over pay-for-delay [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 31]. Available from: www.gabionline.net/Policies-Legislation/EU-Court-of-Justice-upholds-Lundbeck-fines-over-pay-for-delay
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